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A New Oral Treatment For Type II Diabetes Mellitus

19 марта 2018 г. обновлено: GlaxoSmithKline

A 12-Week, Parallel-Group, Double-Blind, Randomized, Placebo-Controlled, Multicenter, Dose Ranging Study to Evaluate the Efficacy, Safety and Tolerability of Denagliptin, Administered Orally, Once Daily, as Monotherapy in Subjects With Type 2 Diabetes Mellitus Followed by a 12-week Active Treatment Extension

This is a 24-week study investigating the safety and efficacy of several dosages of a potential new oral medicine for Type II diabetes mellitus.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Подробное описание

A 12-Week, Parallel-Group, Double-Blind, Randomized, Placebo-Controlled, Multicenter, Dose Ranging Study to Evaluate the Efficacy, Safety and Tolerability of GW823093, Administered Orally, Once Daily, as Monotherapy in Subjects With Type 2 Diabetes Mellitus followed by a 12-week Active Treatment Extension

Тип исследования

Интервенционный

Регистрация (Действительный)

375

Фаза

  • Фаза 2

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

  • Германия
    • Baden-Wuerttemberg
      • Bammental, Baden-Wuerttemberg, Германия, 69245
        • GSK Investigational Site
      • Deggingen, Baden-Wuerttemberg, Германия, 73326
        • GSK Investigational Site
      • Heidelberg, Baden-Wuerttemberg, Германия, 69120
        • GSK Investigational Site
      • Kippenheim, Baden-Wuerttemberg, Германия, 77971
        • GSK Investigational Site
      • Koenigsfeld, Baden-Wuerttemberg, Германия, 78126
        • GSK Investigational Site
      • Offenburg, Baden-Wuerttemberg, Германия, 77654
        • GSK Investigational Site
      • Sinsheim, Baden-Wuerttemberg, Германия, 74889
        • GSK Investigational Site
      • Stockach, Baden-Wuerttemberg, Германия, 78333
        • GSK Investigational Site
      • Weinheim, Baden-Wuerttemberg, Германия, 69469
        • GSK Investigational Site
    • Bayern
      • Haag, Bayern, Германия, 83527
        • GSK Investigational Site
      • Hoehenkirchen-Siegertsbrunn, Bayern, Германия, 85635
        • GSK Investigational Site
    • Hessen
      • Bad Kreuznach, Hessen, Германия, 55545
        • GSK Investigational Site
      • Hirschhorn, Hessen, Германия, 69434
        • GSK Investigational Site
      • Kelkheim, Hessen, Германия, 65779
        • GSK Investigational Site
      • Offenbach, Hessen, Германия, 63067
        • GSK Investigational Site
      • Offenbach, Hessen, Германия, 63073
        • GSK Investigational Site
    • Niedersachsen
      • Bad Lauterberg, Niedersachsen, Германия, 37431
        • GSK Investigational Site
      • Lueneburg, Niedersachsen, Германия, 21335
        • GSK Investigational Site
      • Tostedt, Niedersachsen, Германия, 21255
        • GSK Investigational Site
    • Rheinland-Pfalz
      • Ingelheim, Rheinland-Pfalz, Германия, 55218
        • GSK Investigational Site
      • Mainz, Rheinland-Pfalz, Германия, 55116
        • GSK Investigational Site
      • Rhaunen, Rheinland-Pfalz, Германия, 55624
        • GSK Investigational Site
      • Speyer, Rheinland-Pfalz, Германия, 67346
        • GSK Investigational Site
    • Sachsen
      • Dresden, Sachsen, Германия, 01129
        • GSK Investigational Site
      • Dresden, Sachsen, Германия, 01219
        • GSK Investigational Site
      • Freital, Sachsen, Германия, 01705
        • GSK Investigational Site
      • Pirna, Sachsen, Германия, 01796
        • GSK Investigational Site
      • Schmiedeberg, Sachsen, Германия, 01762
        • GSK Investigational Site
  • Греция
      • Athens, Греция, 115 26
        • GSK Investigational Site
      • Heraklion, Crete, Греция, 71409
        • GSK Investigational Site
      • Lavrio, Греция, 19500
        • GSK Investigational Site
      • Melissia, Греция, 15127
        • GSK Investigational Site
      • Thessaloniki, Греция, 564 29
        • GSK Investigational Site
      • Thessaloniki, Греция, 546 42
        • GSK Investigational Site
      • Thessaloniki, Греция, 551 32
        • GSK Investigational Site
      • Thessaloniki, Греция, 564 34
        • GSK Investigational Site
  • Канада
    • British Columbia
      • Coquitlam, British Columbia, Канада, V3K 3P4
        • GSK Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Канада, R3E 3P4
        • GSK Investigational Site
    • Newfoundland and Labrador
      • Bay Roberts, Newfoundland and Labrador, Канада, A0G 1G0
        • GSK Investigational Site
    • Ontario
      • Brampton, Ontario, Канада, L6T 3T1
        • GSK Investigational Site
      • Toronto, Ontario, Канада, M9W 4L6
        • GSK Investigational Site
      • Toronto, Ontario, Канада, M4R 2G4
        • GSK Investigational Site
      • Waterloo, Ontario, Канада, N2J 1C4
        • GSK Investigational Site
    • Quebec
      • Gatineau, Quebec, Канада, J8Y 6S8
        • GSK Investigational Site
      • Mirabel, Quebec, Канада, J7J 2K8
        • GSK Investigational Site
      • Pointe-Claire, Quebec, Канада, H9R 4S3
        • GSK Investigational Site
      • Sainte-Foy, Quebec, Канада, G1W 4R4
        • GSK Investigational Site
      • Sherbrooke, Quebec, Канада, J1H 4J6
        • GSK Investigational Site
  • Латвия
      • Jelgava, Латвия, LV 3001
        • GSK Investigational Site
      • Ogre, Латвия, LV 5001
        • GSK Investigational Site
      • Riga, Латвия, LV 1002
        • GSK Investigational Site
      • Riga, Латвия, LV1079
        • GSK Investigational Site
      • Riga, Латвия, LV1002
        • GSK Investigational Site
      • Talsi, Латвия, LV 3201
        • GSK Investigational Site
      • Valmiera, Латвия, LV 4201
        • GSK Investigational Site
  • Пуэрто-Рико
      • Ponce, Пуэрто-Рико, 00716
        • GSK Investigational Site
  • Румыния
      • Brasov, Румыния, 500366
        • GSK Investigational Site
      • Bucharest, Румыния, 020475
        • GSK Investigational Site
      • Bucharest, Румыния, 020045
        • GSK Investigational Site
  • Соединенные Штаты
    • California
      • Long Beach, California, Соединенные Штаты, 90806
        • GSK Investigational Site
      • Pasadena, California, Соединенные Штаты, 91105
        • GSK Investigational Site
    • Colorado
      • Denver, Colorado, Соединенные Штаты, 80220
        • GSK Investigational Site
    • Florida
      • Hollywood, Florida, Соединенные Штаты, 33021
        • GSK Investigational Site
      • Miami, Florida, Соединенные Штаты, 33126
        • GSK Investigational Site
    • Georgia
      • Atlanta, Georgia, Соединенные Штаты, 30308
        • GSK Investigational Site
      • Marietta, Georgia, Соединенные Штаты, 30066
        • GSK Investigational Site
    • Hawaii
      • Honolulu, Hawaii, Соединенные Штаты, 96813
        • GSK Investigational Site
    • Illinois
      • Chicago, Illinois, Соединенные Штаты, 60607
        • GSK Investigational Site
    • Indiana
      • Indianapolis, Indiana, Соединенные Штаты, 46202
        • GSK Investigational Site
    • Louisiana
      • Sunset, Louisiana, Соединенные Штаты, 70584
        • GSK Investigational Site
    • Maryland
      • Oxon Hill, Maryland, Соединенные Штаты, 20745
        • GSK Investigational Site
    • Nevada
      • Las Vegas, Nevada, Соединенные Штаты, 89106
        • GSK Investigational Site
      • Pahrump, Nevada, Соединенные Штаты, 89048
        • GSK Investigational Site
    • New York
      • Albany, New York, Соединенные Штаты, 12208
        • GSK Investigational Site
      • Buffalo, New York, Соединенные Штаты, 14209
        • GSK Investigational Site
      • Johnson City, New York, Соединенные Штаты, 13790
        • GSK Investigational Site
      • Rochester, New York, Соединенные Штаты, 14642
        • GSK Investigational Site
      • Syracuse, New York, Соединенные Штаты, 13210
        • GSK Investigational Site
    • North Carolina
      • Durham, North Carolina, Соединенные Штаты, 27710
        • GSK Investigational Site
      • Raleigh, North Carolina, Соединенные Штаты, 27612
        • GSK Investigational Site
    • Ohio
      • Cincinnati, Ohio, Соединенные Штаты, 45246
        • GSK Investigational Site
      • Kettering, Ohio, Соединенные Штаты, 45429
        • GSK Investigational Site
    • Pennsylvania
      • Jefferson Hills, Pennsylvania, Соединенные Штаты, 15025
        • GSK Investigational Site
      • Sewickley, Pennsylvania, Соединенные Штаты, 15143
        • GSK Investigational Site
    • South Carolina
      • Columbia, South Carolina, Соединенные Штаты, 29201
        • GSK Investigational Site
    • Tennessee
      • Kingsport, Tennessee, Соединенные Штаты, 37660
        • GSK Investigational Site
    • Texas
      • Arlington, Texas, Соединенные Штаты, 76017
        • GSK Investigational Site
      • Dallas, Texas, Соединенные Штаты, 75246
        • GSK Investigational Site
      • Dallas, Texas, Соединенные Штаты, 75230
        • GSK Investigational Site
      • San Antonio, Texas, Соединенные Штаты, 78237
        • GSK Investigational Site
    • Utah
      • Salt Lake City, Utah, Соединенные Штаты, 84102
        • GSK Investigational Site
    • Virginia
      • Burke, Virginia, Соединенные Штаты, 22015
        • GSK Investigational Site
    • Washington
      • Bellingham, Washington, Соединенные Штаты, 98226
        • GSK Investigational Site
      • Tacoma, Washington, Соединенные Штаты, 98403
        • GSK Investigational Site
      • Vancouver, Washington, Соединенные Штаты, 98664
        • GSK Investigational Site
  • Финляндия
      • Helsinki, Финляндия, 00260
        • GSK Investigational Site
      • Kuopio, Финляндия, 70210
        • GSK Investigational Site
      • Oulu, Финляндия, 90100
        • GSK Investigational Site
  • Чехия
      • Brno, Чехия, 656 51
        • GSK Investigational Site
      • Ceske Budejovice, Чехия, 370 87
        • GSK Investigational Site
      • Cheb, Чехия, 350 02
        • GSK Investigational Site
      • Liberec, Чехия, 46004
        • GSK Investigational Site
      • Praha 2, Чехия, 128 21
        • GSK Investigational Site
      • Praha 5, Чехия, 158 00
        • GSK Investigational Site
      • Praha 5, Чехия, 150 05
        • GSK Investigational Site
      • Trebic, Чехия, 674 01
        • GSK Investigational Site
  • Швеция
      • Göteborg, Швеция, SE-413 45
        • GSK Investigational Site
      • Malmö, Швеция, SE-205 02
        • GSK Investigational Site
      • Stockholm, Швеция, SE-182 88
        • GSK Investigational Site

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 18 лет до 75 лет (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

Inclusion criteria:

  • Women must not be pregnant and must not be breastfeeding.
  • Have Type II diabetes.
  • Not taking any medicine for diabetes, or taking one oral medicine for their diabetes.

Exclusion criteria:

  • Have any underlying or significant active disease that would prevent the subject from safely participating in the trial by the judgement of the study doctor.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Двойной

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Плацебо Компаратор: Placebo
Participants received oral dose of matching placebo capsule to denagliptin (DEN) once daily in the morning, 30 minutes (min) prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 milligram (mg) once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.
Лекарство: Placebo
Placebo capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.
Экспериментальный: DEN 2.5 mg
Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.
Лекарство: DEN 2.5 mg
DEN 2.5 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.
Другие имена:
  • GW823093 2.5 mg
Экспериментальный: DEN 7.5 mg
Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.
Лекарство: DEN 7.5 mg
DEN 7.5 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.
Другие имена:
  • GW823093 7.5 mg
Экспериментальный: DEN 15 mg
Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.
Лекарство: DEN 15 mg
DEN 15 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.
Другие имена:
  • GW823093 15 mg
Экспериментальный: DEN 30 mg
Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.
Лекарство: DEN 30 mg
DEN 30 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.
Другие имена:
  • GW823093 30 mg
Экспериментальный: DEN 45 mg
Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.
Лекарство: DEN 45 mg
DEN 45 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.
Другие имена:
  • GW823093 45 mg

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12
Временное ограничение: Baseline (Week 0) and Week 12
HbA1c is used to show in participants with diabetes, how well their diabetes is being controlled. The HbA1c test gives the average blood glucose levels over the pervious two to three months. The sample for HbA1c assessment was collected at Visit 5 (Week 0) and Visit 12 (Week 12). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 12) value. Analysis of covariance (ANCOVA) model for analysis was used with the terms for gender, prior therapy (diet & exercise/monotherapy), treatment, region and Baseline measurement (continuous covariate). Last observation carried forward (LOCF) dataset defined as carrying forward of the last valid observation recorded on-treatment (scheduled or unscheduled) for participants who withdrew from the study to all remaining main phase visits was used. Adjusted mean is reported as least square (LS) mean.
Baseline (Week 0) and Week 12

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change From Baseline in HbA1c at Week 4, 8, 16, 20 and 24
Временное ограничение: Baseline (Week 0) up to Week 24
HbA1c is use d to show in participants with diabetes, how well their diabetes is being controlled. The HbA1c test gives the average blood glucose levels over the pervious two to three months. The sample for HbA1c assessment was collected at Visit 5 (Week 0), Visit 9 (Week 4), Visit 11 (Week 8), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 4, Week 8, Week 16, Week 20 and Week 24) values.
Baseline (Week 0) up to Week 24
Change From Baseline in FPG at Week 12
Временное ограничение: Baseline (Week 0) and Week 12
The glycemic assessment of FPG measures a participant's blood sugar level after fasting or not eating anything for at least eight hours (h). The samples of FPG was collected was collected at Visit 5 (Week 0) and Visit 12 (Week 12). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 12) value. ANCOVA model for analysis was used with the terms for gender, prior therapy (diet & exercise/monotherapy), treatment, region and Baseline measurement (continuous covariate). Adjusted mean is reported as LS mean.
Baseline (Week 0) and Week 12
Change From Baseline in FPG at Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24
Временное ограничение: Baseline (Week 0) up to Week 24
The glycemic assessment of FPG measures a participant's blood sugar level after fasting or not eating anything for at least eight h. The sample for FPG assessment was collected at Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 1, 2, 3, 4, 6, 8, 13, 14, 15, 16, 20 and 24) values.
Baseline (Week 0) up to Week 24
Number of Participants Who Were HbA1c Responders at Week 12
Временное ограничение: Week 12
HbA1c is used to show in participants with diabetes, how well their diabetes is being controlled. The HbA1c test gives the average blood glucose levels over the pervious two to three months. The responders were defined as HbA1c values of <=6.5%, <7% and HbA1c reduction of >=0.7%. Analysis was done based on a logistic regression model with terms included for treatment, gender, prior therapy and Baseline measurement.
Week 12
Number of Participants of FPG Responders at Week 12
Временное ограничение: Week 12
The glycemic assessment of FPG measures a participant's blood sugar level after fasting or not eating anything for at least eight h. The responders were defined as FPG value of <7 mmol/L and FPG reduction value of >=1.7 mmol/L. Analysis was done based on a logistic regression model with terms included for treatment, gender, prior therapy and Baseline measurement.
Week 12
Change From Baseline in Fructosamine at Week 12
Временное ограничение: Baseline (Week 0) and Week 12
The sample for fructosamine (total and corrected protein) assessment was collected at Visit 5 (Week 0) and Visit 12 (Week 12). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 12) value. ANCOVA model for analysis was used with the terms for gender, prior therapy (diet & exercise/monotherapy), treatment, region and Baseline measurement (continuous covariate). Adjusted mean is reported as LS mean.
Baseline (Week 0) and Week 12
Change From Baseline in Fructosamine at Weeks 4, 8, 16, 20 and 24
Временное ограничение: Baseline (Week 0) up to Week 24
The sample for fructosamine (total and corrected protein) assessment was collected at Visit 5 (Week 0), Visit 9 (Week 4), Visit 11 (Week 8), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 4, 8, 16, 20 and 24) values.
Baseline (Week 0) up to Week 24
Change From Baseline in Fasting Serum Insulin and Pro-insulin at Week 12
Временное ограничение: Baseline (Week 0) and Week 12
The assessment of fasting serum insulin measures a participant's serum insulin level after fasting or not eating anything for at least eight h. The sample for fasting serum insulin and pro-insulin was collected at Visit 5 (Week 0) and Visit 12 (Week 12). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 12) value. ANCOVA model for analysis was used with the terms for gender, prior therapy (diet & exercise/monotherapy), treatment, region and baseline measurement (continuous covariate). Adjusted mean is reported as LS mean.
Baseline (Week 0) and Week 12
Change From Baseline in Fasting Serum Insulin at Weeks 4, 8, 16, 20, 24 and Pro-insulin at Weeks 4 and 8
Временное ограничение: Baseline (Week 0) up to Week 24
The assessment of fasting serum insulin measures a participant's serum insulin level after fasting or not eating anything for at least eight h. The sample for fasting serum insulin was collected at Visit 5 (Week 0) Visit 9 (Week 4), Visit 11 (Week 8), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). The sample for pro-insulin was collected at Visit 5 (Week 0), Visit 9 (Week 4) and Visit 11 (Week 8). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 4, 8, 16, 20 and 24) values.
Baseline (Week 0) up to Week 24
Change From Baseline in Pro-insulin at Week 16, 20 and 24.
Временное ограничение: Baseline (Week 0) up to Week 24
The sample for pro-insulin was collected at Visit 5 (Week 0), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 16, 20 and 24) values.
Baseline (Week 0) up to Week 24
Change From Baseline in Pro-insulin to Insulin Ratio at Week 12
Временное ограничение: Baseline (Week 0) and Week 12
The samples for pro-insulin and insulin was collected at Visit 5 (Week 0) and Visit 12 (Week 12). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 12) value. ANCOVA model for analysis was used with the terms for gender, prior therapy (diet & exercise/monotherapy), treatment, region and baseline measurement (continuous covariate). Adjusted mean is reported as LS mean.
Baseline (Week 0) and Week 12
Change From Baseline in Pro-insulin to Insulin Ratio at Week 4 and 8
Временное ограничение: Baseline (Week 0) and Week 4 and 8
The samples for pro-insulin and insulin was collected at Visit 5 (Week 0), Visit 9 (Week 4) and Visit 11 (Week 8). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 4 and 8) values. ANCOVA model for analysis was used with the terms for gender, prior therapy (diet & exercise/monotherapy), treatment, region and baseline measurement (continuous covariate). Adjusted mean is reported as LS mean.
Baseline (Week 0) and Week 4 and 8
Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE) and Events of Hypoglycaemia
Временное ограничение: Up to Week 25
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition. Medications that lowered blood glucose were capable of producing hypoglycemia or symptoms of hypoglycemia. Participants were provided with a hypoglycemic symptoms log at each visit and were asked to record symptoms of hypoglycemia.
Up to Week 25
Number of Participants With AE and Event of Hypoglycaemia of Mild, Moderate and Severe
Временное ограничение: Up to Week 25
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Medications that lowered blood glucose were capable of producing hypoglycemia or symptoms of hypoglycemia. Participants were provided with a hypoglycemic symptoms log at each visit and were asked to record symptoms of hypoglycemia. The assessment of severity was done by the investigator. A mild AE was defined as an event that was easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities. A moderate AE was defined as an event that was sufficiently discomforting to interfere with normal everyday activities. A severe AE was defined as an event that prevents normal everyday activities.
Up to Week 25
Number of Participants With Change From Baseline Value of Potential Clinical Concern (PCC) in Vital Signs at Any Time During Therapy
Временное ограничение: Baseline (Week 0) up to Week 24
The vital sign assessments include systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR). The assessments were done pre-dose at Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 12 (Week 12), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 1 to 24) values. The criteria for PCC included: HR increase or decrease from Baseline >30 beats per minute (bpm) and <50 or >120 bpm; SBP increase or decrease from Baseline >30 millimeter of mercury (mmHg) in the same posture and >170 or <100 mmHg; increase or decrease from Baseline >20 mmHg in same posture and >110 or <50 mmHg.
Baseline (Week 0) up to Week 24
Change From Baseline in Body Weight Over Time
Временное ограничение: Baseline (Week 0) and Week -5 to 25 (Follow-up)
The assessment of body weight was done during the run-in phase, randomized treatment phase and Follow-up at Visit 2 (Week -5), Visit 3 (Week -4), Visit 4 (Week -2), Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 12 (Week 12), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20), Visit 12 (Week 12), Visit 18 (Week 24) and Visit 19 (Week 25). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week -5 to 24) values.
Baseline (Week 0) and Week -5 to 25 (Follow-up)
Change From Baseline in Body Mass Index (BMI) Over Time
Временное ограничение: Baseline (Week 0) and Week -5 to 25 (Follow-up)
BMI is an estimated the body fat of the participants, based on body weight divided by height squared. Height was assessed at Screening (Visit 2, Week -5) and confirmed at Baseline (Visit 5, Week 0). Weight was assessed at all Visits (Visit -5 to Visit 19). BMI was calculated during the run-in phase, randomized treatment phase and Follow-up at Visit 2 (Week -5), Visit 3 (Week -4), Visit 4 (Week -2), Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 12 (Week 12), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20), Visit 12 (Week 12), Visit 18 (Week 24) and Visit 19 (Week 25). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week -5 to 24) values.
Baseline (Week 0) and Week -5 to 25 (Follow-up)
Change From Baseline in Waist Circumference and Hip Circumference Over Time
Временное ограничение: Baseline (Week 0) up to Week 24
Waist and hip measurements were done at Screening (Visit 2, Week -5), Visit 5 (Week 0), Visit 12 (Week 12) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week -5 to 24) values.
Baseline (Week 0) up to Week 24
Mean Change From Baseline in Waist to Hip Ratio Over Time
Временное ограничение: Baseline (Week 0) up to Week 24
Waist to hip ratio calculation from the waist and hip measurements were done at Screening (Visit 2, Week -5), Visit 5 (Week 0), Visit 12 (Week 12) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week -5 to 24) values.
Baseline (Week 0) up to Week 24
Change From Baseline in 12-lead ECG Over Time
Временное ограничение: Baseline (Week 0) up to Week 24
12-lead ECGs were obtained during the study using an ECG machine that automatically calculated the HR and measured PR, QRS, RR, QT, and QTc intervals. The mean PR interval, RR interval, QRS duration, uncorrected QT interval (UncQT) and QTcB (QT corrected by Bazett's formula) and QTcF (corrected by Friedericia's formula) was calculated from automated ECG readings. ECG was read centrally and locally at Visit 2 (Week -5), Visit 5 (Week 0), Visit 9 (Week 4), Visit 12 (Week 12), Visit 16 (Week 16) and Visit 18 (Week 24). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week -5 to 24) values.
Baseline (Week 0) up to Week 24
Number of Participants With Laboratory Clinical Chemistry Values of PCC at Any Time on Therapy
Временное ограничение: Up to Week 24
The parameters of clinical chemistry included sodium, potassium, chloride, bicarbonate, lactate dehydrogenase ([LDH] if >2x upper limit of reference range, LDH isoenzymes were collected), total protein, albumin, blood urea nitrogen (BUN), creatinine, total bilirubin, direct bilirubin, alkaline phosphatase (ALP), aspartate transaminase (AST), alanine transaminase (ALT), Calcium, phosphorus (inorganic) and uric acid. The assessments were done at Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 12 (Week 12), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Only those parameters for which at least one value of PCC was reported are summarized.
Up to Week 24
Number of Participants With Laboratory Haematology Values of PCC at Any Time on Therapy
Временное ограничение: Up to Week 24
The parameters of hematology included red blood cell (RBC) count, hemoglobin, hematocrit, platelet count and total white blood cell (WBC) count. The assessments were done at Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 12 (Week 12), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20) and Visit 18 (Week 24). Only those parameters for which at least one value of PCC was reported are summarized.
Up to Week 24
Number of Participants With Abnormal Urinalysis Dipstick Result
Временное ограничение: Up to Follow-up (Week 25)
The parameters of dipstick urinalysis included glucose, bilirubin, protein and ketones. The abnormal results of dispstick parameters were categorized for glucose as trace or 1/10 gram (g)/deciliter (dL %), 1+ or ¼ g/dL (%), 2+ or ½ g/dL (%), 3+ or 1 g/dL (%); for ketones as 1+ and trace; for proteins as 1+, 2+, 3+ and trace. The assessments were done at Visit 2 (Week -5), Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 12 (Week 12), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20), Visit 18 (Week 24) and Visit 19 (Week 25).
Up to Follow-up (Week 25)
Number of Participants With Urinalysis Microscopic Result
Временное ограничение: Up to Follow-up (Week 25)
The parameters of microscopic urinalysis included RBC and WBC. The microscopic urinalysis results for the parameters were categorized as cells of 0-1, 1-3, 3-5, 5-10, 10-15, 15-25, 25-50, 50-100 and innumerable. The assessments were done at Visit 2 (Week -5), Visit 5 (Week 0), Visit 6 (Week 1), Visit 7 (Week 2), Visit 8 (Week 3), Visit 9 (Week 4), Visit 10 (Week 6), Visit 11 (Week 8), Visit 12 (Week 12), Visit 13 (Week 13), Visit 14 (Week 14), Visit 15 (Week 15), Visit 16 (Week 16), Visit 17 (Week 20), Visit 18 (Week 24) and Visit 19 (Week 25).
Up to Follow-up (Week 25)
Population Pharmacokinetic (PK) Parameter of Plasma Concentration of DEN
Временное ограничение: Pre-dose at Week 0, 0.5 to 1.5 h post-dose at Week 4, 12, 16 or 20, 2 to 4 h post-dose at Week 4, 12, 16 or 20 and 6 to 10 h post-dose at Week 4, 12, 16 or 20
A total of 6 blood samples, 2 milliliter each were planned to be obtained over the course of the study for determination of DEN plasma concentrations. For each PK sampling visit a sampling interval was defined. PK samples were planned to be collected at any time during the defined sampling intervals.
Pre-dose at Week 0, 0.5 to 1.5 h post-dose at Week 4, 12, 16 or 20, 2 to 4 h post-dose at Week 4, 12, 16 or 20 and 6 to 10 h post-dose at Week 4, 12, 16 or 20
Descriptive Statistics of Dipeptidyl Peptidase-IV (DPP-IV) Inhibition Performed as Part of the Population PK
Временное ограничение: Pre-dose at Week 0, 0.5 to 1.5 h post-dose at Week 4, 12, 16 or 20, 2 to 4 h post-dose at Week 4, 12, 16 or 20 and 6 to 10 h post-dose at Week 4, 12, 16 or 20
A total of 6 blood samples, 2 milliliter each were planned to be obtained over the course of the study for determination of DPP-IV inhibition. For each PK sampling visit a sampling interval was defined. PK samples were planned to be collected at any time during the defined sampling intervals.
Pre-dose at Week 0, 0.5 to 1.5 h post-dose at Week 4, 12, 16 or 20, 2 to 4 h post-dose at Week 4, 12, 16 or 20 and 6 to 10 h post-dose at Week 4, 12, 16 or 20

Соавторы и исследователи

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Спонсор

GlaxoSmithKline

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Полезные ссылки

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

28 апреля 2005 г.

Первичное завершение (Действительный)

1 июля 2006 г.

Завершение исследования (Действительный)

21 июля 2006 г.

Даты регистрации исследования

Первый отправленный

25 мая 2005 г.

Впервые представлено, что соответствует критериям контроля качества

25 мая 2005 г.

Первый опубликованный (Оценивать)

26 мая 2005 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

21 марта 2018 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

19 марта 2018 г.

Последняя проверка

1 марта 2018 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • DPB100925

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

ДА

Описание плана IPD

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Данные исследования/документы

  1. Индивидуальный набор данных участников
    Информационный идентификатор: 100925
    Информационные комментарии: For additional information about this study please refer to the GSK Clinical Study Register
  2. Отчет о клиническом исследовании
    Информационный идентификатор: 100925
    Информационные комментарии: For additional information about this study please refer to the GSK Clinical Study Register
  3. Спецификация набора данных
    Информационный идентификатор: 100925
    Информационные комментарии: For additional information about this study please refer to the GSK Clinical Study Register
  4. Форма информированного согласия
    Информационный идентификатор: 100925
    Информационные комментарии: For additional information about this study please refer to the GSK Clinical Study Register
  5. Аннотированная форма отчета о случае
    Информационный идентификатор: 100925
    Информационные комментарии: For additional information about this study please refer to the GSK Clinical Study Register
  6. Протокол исследования
    Информационный идентификатор: 100925
    Информационные комментарии: For additional information about this study please refer to the GSK Clinical Study Register
  7. План статистического анализа
    Информационный идентификатор: 100925
    Информационные комментарии: For additional information about this study please refer to the GSK Clinical Study Register

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

Клинические исследования Placebo

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